# Kj Meditech Co., Ltd.

- Location (FDA's records): Fullerton, CA
- FDA decisions: 13 (2006–2022): 13 510(k) clearances
- Names in FDA's records: Kj Meditech Co., Ltd. (12); Kj Meditech (1)
- Product codes: DZE (11), DZB (1), NHA (1)
- 510(k) review time since 2016: median 474 days, against 221 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 40 (7 its own); citations of its devices by later devices: 13 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bicon, Inc.: 11 (https://510kreport.com/company/bicon)
- Osstem Implant Co., Ltd.: 5 (https://510kreport.com/company/osstem-implant)
- Nobelpharma USA, Inc.: 3 (https://510kreport.com/company/nobelpharma-usa)
- Nobel Biocare Uas, Inc.: 2 (https://510kreport.com/company/nobel-biocare-uas)
- Intra-Lock International: 2 (https://510kreport.com/company/intra-lock-international)
- Jeil Medical Corporation: 1 (https://510kreport.com/company/jeil-medical)
- Osseofuse, Inc.: 1 (https://510kreport.com/company/osseofuse)
- Implant Direct, LLC: 1 (https://510kreport.com/company/implant-direct)

## Firms that cite its devices most
- Medimecca Co., Ltd.: 2 (https://510kreport.com/company/medimecca)
- LK Consulting Group USA, Inc.: 2 (https://510kreport.com/company/lk-consulting-group-usa)
- Csm Implant: 1 (https://510kreport.com/company/csm-implant)
- Seum Medi Co., Ltd.: 1 (https://510kreport.com/company/seum-medi)

## Its most-cited devices
- K121047: Hero II Dental Implant System, IS Dental Implant System (2012), cited by 7
- K112787: Kerator (2012), cited by 3
- K161923: J2A SLA Dental Implant System (2017), cited by 1
- K150060: J2A Dental Implant System, J2C Dental Implant System (2015), cited by 1
- K103810: KJ Submerged System (2011), cited by 1

## Recent decisions
- K202046: LOTA SLA Dental Implant System and LOTA HA Dental Implant System (Mar 1, 2022)
- K173116: KJ ZIRCONIA Implant System (Jun 28, 2018)
- K161923: J2A SLA Dental Implant System (Nov 9, 2017)
- K151970: KJ Mini Implant System (Oct 21, 2016)
- K150060: J2A Dental Implant System, J2C Dental Implant System (Apr 2, 2015)
- K140052: J2I Implant System (Oct 30, 2014)
- K140051: KJ External Implant System (Oct 30, 2014)
- K121098: Hero I Dental Implant System (Jan 17, 2013)

Source page: https://510kreport.com/company/kj-meditech